Human research ethics review at Western comprises three different boards:

• The health science research ethics board (HSREB), which reviews studies in clinical settings and those involving physical interventions or procedures;
• The non-medical research ethics board (NMREB), which reviews social, behavioural cultural and humanities research; and
• The cadaveric research ethics board (CREB), which reviews all projects requesting specimens from the body bequeathal program at Western.

If you are unsure to which board to submit, please contact a human research ethics officer prior to beginning an application. With the exception of hospital-affiliated studies, there may be instances where, despite the participants and setting being health-related, the application of social science theory warrants NMREB review.

If your project is hospital-affiliated please complete the ReDA application first and then use the export button within ReDA to begin a new application within the WREM system and link the two forms.

Within the Heath Science Research Ethics Board (HSREB) we have 3 Levels of review:

• HSREB full board 
  
  • Research involving vulnerable populations 
  • There is an unknown, moderate or high physical or psychological risk to participants 
  • Research that takes place during a medical/surgical procedure 
• HSREB delegated level 2: prospective research 
  
  • Research takes place, or uses equipment, in a medical or health care setting  
  • Uses or relates to medical health records  
  • Research that is deemed minimal-risk to patients and participants 
• HSREB delegated level 1: retrospective research 
  
  • Chart reviews or use of existing databases of information that is available prior to the research project beginning 
  • Note: Only one date range extension amendment for delegated level 1 studies will be approved by the HSREB. Any further date range extensions will require a delegated level 2 submission.

How to Submit a Protocol 

The HSREB requires a protocol for all submissions. The protocol and supporting documentation must be submitted electronically using the full board health sciences form in WesternREM (WREM). For guidance on writing a protocol see the board's guidance document on our Guidelines and Templates page under HSREB.

How to submit revised study documents 

Once recommendations have been received from the HSREB researchers need to respond to these recommendations and include revised documents (e.g., protocol, letter of information, etc.) Please ensure to submit one copy with tracked changes (in Word format) and a clean copy of all revised study document(s) in the appropriate questions within the WREM application form. 

All revised study documents must have version dates including the day, written month and year (e.g., dd/mm/yyyy) in the footer of all study documents. Version dates identify the latest edition of study documents. If a study document requires further modification based on comments received during the review process, the version date must be modified to reflect the most recent edition of the study document. 

Every time an amendment is made to documents, please remember to revise the version date to reflect the changes made and re-submit the entire document.

Submissions requirements

The NMREB needs to understand exactly what a participant will experience in the study, and/or how the researcher will carry out their work involving human participants and/or their data.  This includes providing a full description of study activities, providing any relevant information to the board regarding the context in which the research will be conducted and submitting all supporting documentation, including:

• Study instruments such as surveys, interviews, experimental stimuli, observation guides, data collection forms, etc.;
• Recruitment documents;
• Letters of information and consent documents; and
• Support resources, if applicable.  and providing any relevant information to the board regarding the context in which the research will be conducted.
  
  

How to Submit Revised Documents for Initial Submissions and Amendments

All study documents must have version dates (e.g., dd/mmm/yyyy) in the footer of the document. Version dates identify the latest edition of study documents. Version dates, including the day, written month and year should be included in the footer of all study documents. If a study document requires further modification based on comments received during the review process, the version date must be modified to reflect the most recent edition of the study document.

Please also ensure to submit one copy with tracked changes (in Word format) and a clean copy of all revised study document(s).

The Cadaveric Research Ethics Board (CREB) is responsible for the oversight and review of all research at Western University using cadaveric material from the Body Bequeathal program. The CREB operates under the oversight of the Health Science Research Ethics Board (HSREB). CREB exists to provide responsible stewardship for cadaveric tissue utilized in research at Western University. Our mission is to protect the dignity and privacy of whole-body donors while fostering health research.

Primary Investigators considering using cadaveric material should already have or be ready to apply for a BAPA (Biological Agents Permit Application) via Western University Human Resources and, if necessary, complete hazard communication forms for all participants on the proposed project.

Body Bequeathal Program

Interested PI’s are welcome to reach out to the CREB administrator and/or department of anatomy lab manager to inquire on availability of cadaveric material that originates from Western’s Body Bequeathal Program before submitting the CREB application. If your project cannot be supported by Western’s Body Bequeathal program, PI’s may consider sourcing cadaveric specimens from third party vendors. The chart below highlights the opportunities with each option.

No matter the source of material, all research carried out at Western University using material that meets the criteria of cadaveric specimens will be overseen by the CREB.

Scope and Purview of the Board

2.1 Criterion of Inclusion: We define cadaveric tissue as any human tissues originating from a deceased individual who has donated their whole-body to a body bequeathal program locally, nationally, or internationally.

2.2 Criteria of Exclusions: Cadaveric tissue does not include tissues acquired during a medical procedure (e.g., pathology specimens, etc.), cell lines derived from human tissues (e.g., cancer cell lines, etc.) or constituent parts of a whole-organ obtained from an organ- or disease-specific tissue bank (e.g., brain sections obtained from the Alzheimer’s Institute etc.).

If you have a question about a potential project or application, we invite you to reach out to the Chair or Administrator of the Cadaveric Research Ethics Board for inquiry.

Submitting Revised Documents

All revised study documents must have version dates (e.g., dd/mmm/yyyy) in the footer of all study documents. Version dates identify the latest edition of study documents. If a study document requires further modification based on comments received during the review process, the version date must be modified to reflect the most recent edition of the study document.

Please also ensure to submit one copy with tracked changes (in Word format), and a clean copy of all revised study document(s).